Regulatory Affairs Manager

This role is in support of Almus & Alvita, a Cencora business offering a trusted source of generic pharmaceuticals and a line of quality healthcare products in Europe., To lead and manage the regulatory activities supporting the own brand ranges sold through the Pharmaceutical wholesale business (Alliance Healthcare) which is part of the Cencora Group, in accordance with budgeted NPD and resourcing plans.

To work in collaboration with the European Head of Regulatory Affairs and Pharmacovigilance, Central team and in market teams, in development and extension of the Alvita product range across the UK and continental Europe and into new potential markets in accordance with agreed budget and 5 year growth plan. This role will be responsible for leading and performing a variety of regulatory tasks in relation to pharmaceutical and personal care products and in addition provide functional support to regulatory teams in market.

Under the leadership of the European Head of Regulatory Affairs and Pharmacovigilance, this role will be responsible for managing the submission and co-ordinating the necessary variations of European Procedures, involving multiple markets. This role is pivotal in supporting the development and regulatory maintenance of the Alvita and Almus ranges and potential expansion into new markets, ensuring the own brand products owned by Alliance Healthcare are legally compliant and meet Cencora Group policies and standards.,

• Responsible for managing the regulatory tasks in launching multiple NPD (New product Development) projects as part of a multifunctional team, in accordance with the budget and 5 year plans.
• Support the European Brand Manager and Central Sourcing Team in assessing potential new Alvita products, the launch in new territories, the evaluation of claims and product attributes of products offered by alternative suppliers.
• Review and approve Product Specifications and Artwork Management Sheets (AMS), supporting the launch of new Alvita products and update of existing products. Work collaboratively with other colleagues responsible for originating artwork and provide final approval of artwork for allocated projects.
• Assess the regulatory requirements for products ensuring the product and its labelling are legally compliant.
• Responsible for becoming the subject matter expert on medical devices within the business and ensuring plans are in place to maintain compliance with the requirements of Medical Devices Regulation (EU) 2017/745 and the in Vitro Diagnostic Medical Device Regulation (EU) 2017/746, in the context of our obligations as an own brand.
• Ensure that Regulatory Intelligence data is maintained and updated according to the relevant processes. Demonstrate an innovative approach to obtaining market intelligence from suppliers and/or other sources, which can support the brand and local commercial teams in identifying new product opportunities and developing long-term NPD plans. Support the business on regulatory impacting changes, to ensure the necessary steps are taken to mitigate risk to the business.
• Manage the preparation and submission of the Mutual Recognition Procedure (MRP) and Decentralised Procedure (DCP) Marketing Authorisation Applications (MAAs), involving more than one market.
• Co-ordinate the management of variations with suppliers and local regulatory teams for European Procedures involving more than one market, ensuring all MAs and products in market meet necessary legal compliance.
• Manage the preparation and maintenance of Regulatory Compliance Files with the local affiliates and suppliers for European Procedures involving more than one market.
• Manage the regulatory information within Samarind RMS for European procedures, involving more than one market.
• Contribute as a "key" member of the team responsible for the successful implementation of Identification of Medicinal Products (IDMP) standards into the IT tools and business processes in accordance with legislative deadlines.
• Review and approve promotional materials and content on platforms to ensure compliance with relevant legislation and requirements.
• Support in collaboration with the European Head of Regulatory Affairs and Pharmacovigilance and the local regulatory teams the development of appropriate global and local SOP's and working practices, to optimise the effective handling of regulatory tasks related to Alliance Healthcare product portfolio or the development of new processes necessary to deliver compliance with European and local legislation. Provide training as author and or subject matter expert where applicable.
• Work collaboratively and build strong working relationships with central and local cross-functional teams to manage the assessment of new products and maintenance of existing products in the Alvita and Almus ranges.
• Take a vital role in the Monthly Operational NPD Meetings with the European Business units.
  This role requires someone who is capable of leading the regulatory activities, has excellent…